U.S. patent application number 13/476570 was filed with the patent office on 2012-11-22 for manufacturing electrochemical sensor module.
Invention is credited to James L. Say.
Application Number | 20120291254 13/476570 |
Document ID | / |
Family ID | 47173808 |
Filed Date | 2012-11-22 |
United States Patent
Application |
20120291254 |
Kind Code |
A1 |
Say; James L. |
November 22, 2012 |
MANUFACTURING ELECTROCHEMICAL SENSOR MODULE
Abstract
Certain processes for manufacturing an electrochemical sensor
module include assembly first and second housing portions of sensor
modules; dispensing a sensor fiber across multiple first housing
portions; joining the first and second housing portions; and
separating the sensor modules by cutting the sensor fiber.
Inventors: |
Say; James L.;
(Breckenridge, CO) |
Family ID: |
47173808 |
Appl. No.: |
13/476570 |
Filed: |
May 21, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13129333 |
Jul 19, 2011 |
|
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13476570 |
|
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|
|
61488015 |
May 19, 2011 |
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Current U.S.
Class: |
29/426.2 |
Current CPC
Class: |
A61B 5/1477 20130101;
A61B 5/150358 20130101; A61B 5/150519 20130101; A61B 5/150755
20130101; B29L 2031/753 20130101; A61B 5/1486 20130101; A61B
5/150633 20130101; A61B 5/150297 20130101; B29C 2045/14368
20130101; A61B 5/14532 20130101; A61B 5/150061 20130101; A61B
5/1411 20130101; Y10T 29/49817 20150115; B29C 45/14336 20130101;
A61B 5/150022 20130101; B29C 2045/0067 20130101; A61B 5/150412
20130101; A61B 5/157 20130101; Y10T 156/1052 20150115; A61B 5/14546
20130101; A61B 5/150213 20130101; A61B 5/15142 20130101; B29C
45/0062 20130101 |
Class at
Publication: |
29/426.2 |
International
Class: |
B23P 17/04 20060101
B23P017/04 |
Claims
1. A method of installing sensors in sensor modules, each sensor
module having a first housing portion and a second housing portion,
the method comprising: providing a continuous length of at least a
first composite sensor fiber; disposing the first composite sensor
fiber across a plurality of first housing portions; coupling a
plurality of second housing portions to the first housing portions
to from a plurality of sensors modules, the sensor modules of the
plurality being joined together along the continuous length of the
first composite sensor fiber; and separating the sensor modules of
the plurality by cutting the first composite sensor fiber into
segments.
2. The method of claim 2, wherein the segments of the first
composite sensor fiber form working electrodes.
3. The method of claim 1, further comprising: providing a
continuous length of a second composite sensor fiber; and disposing
the second composite sensor fiber across the plurality of first
housing portions adjacent to the first composite sensor fiber;
wherein separating the sensor modules of the plurality also
includes cutting the second composite sensor fiber into
segments.
4. The method of claim 3, wherein the segments of the first
composite sensor fiber form working electrodes and the segments of
the second composite sensor fiber form counter electrodes.
5. The method of claim 1, further comprising assembling the first
housing portions including disposing a skin-piercing member at each
first housing portion.
6. The method of claim 5, wherein the skin-piercing members are
positioned at the first housing portions before the second housing
portions are coupled to the first housing portions.
7. The method of claim 5, wherein disposing the first composite
sensor fiber across the plurality of first housing portions
comprises disposing the first composite sensor fiber parallel to a
movement axis of the skin-piercing members.
8. The method of claim 5, wherein disposing the first composite
sensor fiber across the plurality of first housing portions
comprises disposing the first composite sensor fiber perpendicular
to a movement axis of the skin-piercing members.
9. The method of claim 1, wherein disposing the first composite
sensor fiber across the plurality of first housing portions
comprises disposing the first composite sensor fiber across a
length of each first housing portion.
10. The method of claim 1, wherein disposing the first composite
sensor fiber across the plurality of first housing portions
comprises disposing the first composite sensor fiber across a width
of each first housing portion.
11. The method of claim 1, wherein disposing the first composite
sensor fiber across the plurality of first housing portions
comprises disposing the first composite sensor fiber across a
portion of each first housing portion.
12. The method of claim 11, wherein the portion is an analysis cell
housing portion.
13. The method of claim 1, further comprising assembling the first
housing portions including disposing electrode contacts at each
first housing portion, the electrode contacts having contact
pads.
14. The method of claim 1, wherein one of the first composite
sensor fiber and the electrode contacts is disposed at a location
offset from another of the first composite sensor fiber and the
electrode contacts.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of application
Ser. No. 13/129,333, filed Jul. 19, 2011, which claims the benefit
of provisional application Ser. No. 61/114,856, filed Nov. 14, 2008
and provisional application Ser. No. 61/488,015, filed May 19,
2011, which applications are incorporated herein by reference in
their entirety.
TECHNICAL FIELD
[0002] The present disclosure relates to manufacturing systems and
processes for producing sensors for measuring bioanalytes and, in
particular, to producing sensors using continuous manufacturing
systems and processes.
BACKGROUND
[0003] Electrochemical bio-sensors have been developed for
detecting analyte concentrations in a given fluid sample. For
example, U.S. Pat. Nos. 5,264,105; 5,356,786; 5,262,035; 5,320,725;
and 6,464,849, which are hereby incorporated herein by reference in
their entireties, disclose wired enzyme sensors for detecting
analytes, such as lactate or glucose. Wired enzyme sensors have
been widely used in blood glucose monitoring systems adapted for
home use by diabetics to allow blood glucose levels to be closely
monitored. Other example types of blood glucose monitoring systems
are disclosed by U.S. Pat. Nos. 5,575,403; 6,379,317; and
6,893,545.
[0004] Conventional manufacturing systems and processes for
producing bio-sensors involve web based conductive print
technology.
SUMMARY
[0005] One aspect of the present disclosure relates to a sensor
system that can be manufactured in reduced scale and that can be
conveniently handled by consumers.
[0006] Another aspect of the present disclosure relates to an
electrochemical sensor module for use in a sensor system that can
be efficiently manufactured using a continuous manufacturing
process such as a continuous insert molding process.
[0007] A further aspect of the present disclosure relates to a
sensor module including a molded body that defines an analyte
analysis cell and also integrates a skin piercing element, such as
a lancet or canula, into the molded body.
[0008] A variety of additional aspects will be set forth in the
description that follows. The aspects can relate to individual
features and to combinations of features. It is to be understood
that both the forgoing general description and the following
detailed description are exemplary and explanatory only and are not
restrictive of the broad concepts upon which the embodiments
disclosed herein are based.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 is a schematic block diagram of a manufacturing
system configured to produce sensor modules in accordance with the
principles of the present disclosure;
[0010] FIG. 2 is a flowchart illustrating an operation flow for an
example manufacturing process by which one or more sensor modules
can be produced, e.g., using the manufacturing system of FIG.
1;
[0011] FIG. 3 is a planar view of a portion of an example carrier
that can be indexed through the processing stations of the
manufacturing system of FIG. 1 in accordance with the principles of
the present disclosure;
[0012] FIG. 4 is a top, perspective view of the portion of the
carrier of FIG. 3 after sensor module components have been molded
onto the body of the carrier in accordance with the principles of
the present disclosure;
[0013] FIG. 5 is a perspective view of the portion of the carrier
of FIG. 4 after a first electrode and a second electrode have been
routed onto the molded sensor components in accordance with the
principles of the present disclosure;
[0014] FIG. 6 is a perspective view of the portion of the carrier
of FIG. 5 after the carrier has been rolled or folded along a fold
axis to align the first and second sections of the carrier body in
accordance with the principles of the present disclosure;
[0015] FIG. 7 is a partial, perspective view of the opposite side
of the portion of the carrier of FIG. 6 after the opposing
components have been secured together in accordance with the
principles of the present disclosure;
[0016] FIG. 8 is a partial, isometric view of the first sensor
module of FIG. 7 after the sensor module has been separated from
the carrier in accordance with the principles of the present
disclosure;
[0017] FIGS. 9 and 10 show another sensor module that can be
manufactured in accordance with the principles of the present
disclosure;
[0018] FIG. 11 is a planar view of a portion of another example
carrier that can be indexed through the processing stations of the
manufacturing system of FIG. 1 in accordance with the principles of
the present disclosure;
[0019] FIG. 12 is a top, perspective view of the portion of the
carrier of FIG. 11 after sensor module components have been molded
onto the body of the carrier in accordance with the principles of
the present disclosure;
[0020] FIG. 13 is a planar view of the portion of the carrier of
FIG. 12 after a first electrode and a second electrode have been
routed onto the molded sensor components in accordance with the
principles of the present disclosure;
[0021] FIG. 14 is a perspective view of the portion of the carrier
of FIG. 13 after the carrier has been folded along a fold axis to
align the first and second sections of the carrier body in
accordance with the principles of the present disclosure;
[0022] FIG. 15 is a perspective view of the opposite side of the
portion of the carrier of FIG. 15 after the opposing components
have been secured together in accordance with the principles of the
present disclosure;
[0023] FIG. 16 illustrates another manufacturing system by which
sensor modules may be assembled;
[0024] FIG. 17 illustrates one example implementation of a first
station of the manufacturing system of FIG. 16 that is configured
to deposit one or more composite sensor fibers onto the first
housing portion of one or more sensor modules;
[0025] FIGS. 18 and 19 are top plan views of example
implementations of the first station of FIG. 17;
[0026] FIG. 20 illustrates one example implementation of a second
station of the manufacturing system of FIG. 16 that is configured
to join together a second housing portion to a first housing
portion to enclose a skin-piercing member and one or more composite
sensor fibers to form a sensor module;
[0027] FIG. 21 illustrates one example implementation of a third
station of the manufacturing system of FIG. 16 that is configured
to separate the sensor modules from each other by cutting the
continuous length of the one or more composite sensor fibers
extending therebetween;
[0028] FIG. 22 shows one example sensor module with composite
sensor fibers positioned between first and second housing portions
parallel to a movement axis of a skin-piercing member; and
[0029] FIG. 23 shows another example sensor module with composite
sensor fibers positioned between first and second housing portions
perpendicular to a movement axis of a skin-piercing member.
DETAILED DESCRIPTION
[0030] Reference will now be made in detail to exemplary aspects of
the present disclosure which are illustrated in the accompanying
drawings. Wherever possible, the same reference numbers will be
used throughout the drawings to refer to the same or like
parts.
[0031] The following definitions are provided for terms used
herein:
[0032] A "working electrode" is an electrode at which the analyte
(or a second compound whose level depends on the level of the
analyte) is electrooxidized or electroreduced with or without the
agency of an electron transfer agent.
[0033] A "reference electrode" is an electrode used in measuring
the potential of the working electrode. The reference electrode
should have a generally constant electrochemical potential as long
as no current flows through it. As used herein, the term "reference
electrode" includes pseudo-reference electrodes. In the context of
the disclosure, the term "reference electrode" can include
reference electrodes which also function as counter electrodes
(i.e., a counter/reference electrode).
[0034] A "counter electrode" refers to an electrode paired with a
working electrode to form an electrochemical cell. In use,
electrical current passes through the working and counter
electrodes. The electrical current passing through the counter
electrode is equal in magnitude and opposite in sign to the current
passing through the working electrode. In the context of the
disclosure, the term "counter electrode" can include counter
electrodes which also function as reference electrodes (i.e., a
counter/reference electrode).
[0035] A "counter/reference electrode" is an electrode that
functions as both a counter electrode and a reference
electrode.
[0036] An "electrochemical sensing system" is a system configured
to detect the presence and/or measure the level of an analyte in a
sample via electrochemical oxidation and reduction reactions on the
sensor. These reactions are converted (e.g., transduced) to an
electrical signal that can be correlated to an amount,
concentration, or level of an analyte in the sample. Further
details about electrochemical sensing systems, working electrodes,
counter electrodes and reference electrodes can be found at U.S.
Pat. No. 6,560,471, the disclosure of which is hereby incorporated
herein by reference in its entirety.
[0037] "Electrolysis" is the electrooxidation or electroreduction
of a compound either directly at an electrode or via one or more
electron transfer agents.
[0038] An "electron transfer agent" is a compound that carries
electrons between the analyte and the working electrode either
directly or in cooperation with other electron transfer agents. One
example of an electron transfer agent is a redox mediator.
[0039] A "sensing layer" is a component of the sensor which
includes constituents that facilitate the electrolysis of the
analyte. The sensing layer may include constituents such as an
electron transfer agent, a catalyst which catalyzes a reaction of
the analyte to produce a response at the electrode, or both.
[0040] The present disclosure is directed to a manufacturing system
configured to produce one or more sensor modules configured for
analyte monitoring (e.g., glucose single-point monitoring, lactate
single-point monitoring, etc.). Each sensor module includes a
housing containing an analysis cell configured to hold a fluid
sample, at least two elongated electrodes arranged to enter the
analysis cell, and contacts for electrically connecting the
electrodes to external connectors. In a preferred embodiment, the
elongated electrodes include a continuously coated working
electrode and an uncoated reference electrode. In one embodiment,
one or more of the elongated electrodes includes a composite
conductive monofilament (CCM) electrode. In other embodiments, the
housing can contain additional electrodes having differing enzyme
coatings. The analysis cell can be configured for coulormetric or
amperometric assays.
[0041] In general, each sensor module is produced by a continuous
manufacturing system, which includes a manufacture and assembly
line in which a preformed carrier travels to different stations
along a direction of travel. Components of the sensor modules are
formed and/or assembled together at different stations as the
carrier progresses through the line. In a preferred embodiment,
each sensor module is produced by a "reel to reel" manufacturing
system in which the carrier extends between first and second reels.
The continuous manufacturing system is particularly suitable for
producing very small parts in production quantities of tens of
millions of units per year per system.
[0042] FIG. 1 is a schematic block diagram of one example
continuous manufacturing system 100 configured to produce a sensor
module in accordance with the principles of the present disclosure.
The manufacturing system 100 includes a carrier 101 extending
between a first carrier reel 102 and a second carrier reel 104. The
carrier 101 travels along a direction of travel D1 from the first
carrier reel 102 to the second carrier reel 104 when indexed by one
or both carrier wheels 102, 104. In one embodiment, the carrier 101
is formed from metal. In another embodiment, the carrier 101 is
formed from a polymer composition. In other embodiments, however,
the carrier 101 can be preformed from any suitable material.
[0043] The manufacturing system 100 also includes a molding station
110, an electrode insertion station 130, a folding station 140, a
joining station 150, a stamping station 160, and a collection
station 170. The carrier 101 passes by each of these stations 110,
130, 140, 150, 160, 170 as the carrier 101 is indexed between the
first and second carrier reels 102, 104. Support components of the
sensor module are formed at the molding station 110. In general,
the molding station 110 overmolds one or more components of each
sensor module onto the carrier 101. In a preferred embodiment, the
molding station 110 includes an in-line injection molding machine.
In various other embodiments, however, different types of molding
machines can be used.
[0044] Electrodes for use in the sensor modules are created by
coating sensor chemistry onto an elongated member (e.g., a
composite monofilament) at a coating station 120. In a preferred
embodiment, the coating station 120 includes at least two filament
reels 106, 108 containing a wound elongated member. Typically, the
elongated member includes a continuously conductive elongated
member. In one embodiment, the elongated member is a composite
monofilament. The elongated member is fed from the first reel 106
to the second reel 108 to continuously coat the elongated member
with a layer of sensor chemistry, such as silver chloride, to form
a working electrode 122. Accordingly, the second reel 108 contains
a wound working electrode 122 when the coating stage is complete.
At least a third filament reel 109 contains a wound, uncoated
elongated member for forming another electrode 124 (e.g., a
reference electrode, a counter electrode, or a reference/counter
electrode).
[0045] The elongated member to be coated can include a thread, a
carbon fiber, a metal wire, or another such elongated member.
Preferably, at least a portion of the elongated member is
electrically conductive. In certain embodiments, each elongated
member can have a composite structure and can include a fiber
having a dielectric core surrounded by a conductive layer suitable
for forming an electrode. A preferred composite fiber is sold under
the name Resistat.RTM. by Shakespeare Conductive Fibers LLC. This
composite fiber includes a composite nylon, monofilament,
conductive thread material made conductive by the suffusion of
about a 1 micron layer of carbonized nylon isomer onto a dielectric
nylon core material. The Resistat.RTM. material is comprised of
isomers of nylon to create the basic 2 layer composite thread.
However, many other polymers are available for the construction,
such as: polyethylene terephthalate, nylon 6, nylon 6,6, cellulose,
polypropylene cellulose acetate, polyacrylonitrile and copolymers
of polyacrylonitrile for a first component and polymers such as of
polyethylene terephthalate, nylon 6, nylon 6,6, cellulose,
polypropylene cellulose acetate, polyacrylonitrile and copolymers
of polyacrylonitrile as constituents of a second component.
Inherently conductive polymers (ICP) such as doped polyanaline or
polypyrolle can be incorporated into the conductive layer along
with the carbon to complete the formulation. In certain
embodiments, the ICP can be used as the electrode surface alone or
in conjunction with carbon. The Resistat.RTM. fiber is availability
in diameters of 0.0025 to 0.016 inches, which as suitable for
sensor electrodes configured in accordance with the principles of
the present disclosure. Example patents disclosing composite fibers
suitable for use in practicing sensor modules configured in
accordance with the principles of the present disclosure include
U.S. Pat. Nos. 3,823,035; 4,255,487; 4,545,835 and 4,704,311, which
are hereby incorporated herein by reference in their
entireties.
[0046] The sensing layers provided at working electrodes 122 of
sensor modules configured in accordance with the principles of the
present disclosure can include a sensing chemistry, such as a redox
compound or mediator. The term redox compound is used herein to
mean a compound that can be oxidized or reduced. Example redox
compounds include transition metal complexes with organic ligands.
Preferred redox compounds/mediators include osmium transition metal
complexes with one or more ligands having a nitrogen containing
heterocycle such as 2,2'-bipyridine. The sensing material also can
include a redox enzyme. A redox enzyme is an enzyme that catalyzes
an oxidation or reduction of an analyte. For example, a glucose
oxidase or glucose dehydrogenase can be used when the analyte is
glucose. Also, a lactate oxidase or lactate dehydrogenase fills
this role when the analyte is lactate. In sensor systems, such as
the one being described, these enzymes catalyze the electrolysis of
an analyte by transferring electrons between the analyte and the
electrode via the redox compound. Further information regarding
sensing chemistry can be found at U.S. Pat. Nos. 5,264,105;
5,356,786; 5,262,035; and 5,320,725, which were previously
incorporated by reference in their entireties.
[0047] The electrodes (e.g., working electrode and reference
electrode) 122, 124 are mounted to the molded components of the
sensor module at the insertion station 130. In general, the second
reel 108 containing the working electrode and the third reel 109
containing the reference electrode (i.e., or counter electrode or
reference/counter electrode) 124 are arranged to feed the
electrodes 122, 124 into the insertion station 130, which aligns
the electrodes 122, 124 with the molded sensor module components.
Typically, the insertion station 130 aligns the elongated members
forming the electrodes 122, 124 with the components on the carrier
101 without cutting the elongated members. In other embodiment,
additional reels holding wound reference electrodes, counter
electrodes, and/or counter/reference electrodes also can be
positioned relative to the insertion station 130 to feed the
electrodes onto the components without cutting the electrodes. This
continuous insertion station 130 allows low cost, high volume
production of CCM-type sensor modules at significantly smaller
sizes, improved repeatability, and with less process waste than
conventional systems and methods.
[0048] The folding station 140 arranges the sensor module
components into a final configuration in which the components are
aligned. In one embodiment, the folding station 140 is configured
to bend the carrier 101 to align two sides of the carrier 101. In
another embodiment, the folding station 140 is configured to break
the carrier along a fold axis to align two sides of the carrier
101. The joining station 150 secures (e.g., presses, welds, molds,
heat seals, etc.) the components together to form the sensor
module. In one embodiment, the joining station 150 includes a laser
welder. In another embodiment, the joining station 150 includes an
overmold machine.
[0049] The separation station 160 separates the sensor modules from
the carrier 101 to produce completed sensor modules. In one
embodiment, the separation station 160 includes a stamping machine.
In another embodiment, the separation station 160 includes a laser
cutting machine. Other types of separation devices also can be used
within the scope of the disclosure. The completed sensor modules
are accumulated at the collection station 170 after being removed
from the carrier 101. The remainder of the carrier 101 is wound
onto the second carrier wheel 104.
[0050] FIG. 2 is a flowchart illustrating an operation flow for an
example manufacturing process 200 by which one or more sensor
modules can be produced using the manufacturing system 100 of FIG.
1. Of course, other systems can implement the steps of
manufacturing process 200 in accordance with the principles of the
present disclosure. The manufacturing process 200 begins at a start
module 210, performs any appropriate initialization procedures, and
proceeds to a form operation 220.
[0051] The form operation 220 produces one or more components of
the sensor module onto the carrier 101 (see FIG. 4). For example,
the form operation 220 can mold a housing of the sensor module onto
the carrier 101. In some embodiments, the form operation 220
produces the housing in a "clamshell" configuration having at least
two opposing portions. For example, in form operation 220, the
carrier 101 can enter an in-line injection molding machine 110,
which simultaneously molds both portions of the housing on the
carrier 101 (see FIG. 1). In a preferred embodiment, the two
opposing portions are half portions. In other embodiments, however,
the opposing portions can be unequal in size and/or shape.
[0052] A coat operation 230 adds sensor chemistry to at least one
elongated member, such as a monofilament, to produce a first
electrode (e.g., a working electrode). In a preferred embodiment,
the coat operation 230 continuously coats sensor chemistry on the
elongated member at a reel-to-reel coating station. For example, in
one embodiment, the elongated member can unwind from a first
filament reel, such as reel 106 of FIG. 1, pass through the sensor
chemistry, and wind up onto a second filament reel, such as reel
108 of FIG. 1, during the coat operation 230. In one embodiment,
the sensor chemistry is continuously coated onto the elongated
member. The coated elongated member is referred to as a working
electrode.
[0053] An insert operation 240 adds the working electrode and a
second electrode (e.g., a reference electrode, a counter electrode,
or a reference/counter electrode) to the molded components arranged
on the carrier 101. Additional electrodes may be added to the
molded components in certain embodiments of the sensor modules. The
insert operation 240 can feed the electrodes 122, 124 of FIG. 1
from the reels 108, 109, respectively, into the insertion station
130 at which the insert operation 240 can route the electrodes into
channels defined in the molded components. The insert operation 240
arranges each electrode to align with a contact element configured
to route any signals generated at the electrode out of the sensor
module housing.
[0054] A fold operation 250 arranges the components and electrodes
of each sensor module into a final configuration. For example, the
fold operation 250 can align and press together two portions of a
sensor module housing to form an enclosure around the coated and
uncoated electrodes. A join operation 260 seals together the
components of the sensor module. For example, the join operation
260 can weld, glue, melt, fasten, or otherwise secure the
components together to form a completed sensor modules. A separate
operation 270 removes (e.g., mechanically cuts, stamps, cuts with a
laser, etc.) the completed sensor modules from the carrier 101
(FIG. 1). The manufacturing process 200 completes and ends at a
stop module 280.
[0055] The principles of the application can be further understood
by walking through an example application in which a generic sensor
module is manufactured. FIG. 3 shows a portion of one example
carrier 101 that can be indexed through the different processing
stations 110, 120, 130, 140, 150, 160 of the manufacturing system
100 of FIG. 1. The carrier 101 includes a generally flat carrier
body 300 defining at least one series of index holes 302 configured
to receive index pins to advance the carrier through the system
100. In the example shown, the carrier body 300 defines four series
of index holes 302. In other embodiments, however, the carrier body
300 can define greater or fewer series of index holes 302.
[0056] The carrier body 300 defines a profile that is configured to
support the components of the sensor module. In a preferred
embodiment, the carrier body 300 is produced by roll stamping a
high-precision profile on a stainless steel or suitable polymer
tape and storing the prepared tape on a collector reel, such as the
first carrier reel 102. One or more components can be molded to the
carrier body 300 as the carrier 101 is indexed. In certain
embodiments, multiple components of one sensor module can be molded
across the width W1 of the carrier body 300.
[0057] The carrier body 300 includes a fold feature 305 that splits
the carrier body 300 into a first section 310 and a second section
320 along a fold axis 304. The first section 310 has a width W2 and
the second section 320 has a width W3. In a preferred embodiment,
the fold feature 305 of the carrier body 300 is a midline fold
feature that splits the carrier body 300 along a central axis into
two halves (i.e., so that the widths W2, W3 of the first and second
sections are about equal). In other embodiments, however, the fold
feature 305 can split the carrier body 300 into sections 310, 320
of different sizes.
[0058] In general, the fold feature 305 is a weakened or reduced
portion of the carrier body 300 at which the carrier body 300 is
configured to bend and/or break. In the example shown, the fold
feature 305 includes multiple connecting members 307 extending
between the first and second sections 310, 320. The connecting
members 307 have a tapered center 308 that is configured to bend to
enable the carrier body 300 to be folded at the fold feature
305.
[0059] Folding the carrier body 300 along the fold axis 304 aligns
the first section 310 with the second section 320. Accordingly, the
fold feature 305 of the carrier body 300 enables opposing portions
of sensor components to be molded onto the first and second
sections 310, 320 of the carrier body 300 and subsequently
assembled together by folding the carrier body 300 along the fold
axis 304. For example, the fold feature 305 enables different
housing portions to be molded face-up on opposite sides of the
carrier body 300. Additional features can be added to the interior
of the sensor module after the support components are molded on the
carrier body 300 and prior to folding the carrier body 300.
[0060] The carrier body 300 shown in FIG. 3 has a profile
configured to support at least two molded components of a sensor
module. Each section 310, 320 includes a first support wall 311,
321 and a second support wall 313, 323 connected by a third support
wall 315, 325, respectively, to form an "H" shape. The support
walls 311, 313, 315 of the first section 310 define first and
second gaps 317, 319 within which components of the sensor modules
can be molded. The support walls 321, 323, 325 of the second
section 320 define first and second gaps 327, 329 within which
opposing components of the sensor modules can be molded.
[0061] First and second support members 312, 314 protrude into the
first gap 317 in the first section 310 from the side walls 311,
313, respectively. Third and fourth support members 316, 318
protrude into the second gap 319 in the first section 310 from the
side walls 311, 313, respectively. The support members 312, 314,
316, 318 are configured to provide support for molded components of
the sensor module. For example, in FIG. 3, each support member 312,
314, 316, 318 defines an opening at an end opposite the support
walls 311, 313 to which a component can be molded. In the example
shown, the third support walls 315, 325 of the two sections 310,
320 also define openings to which components or support members can
be molded.
[0062] FIG. 4 shows the portion of the carrier 101 of FIG. 3 after
sensor module components have been molded onto the body 300 of the
carrier 101 (e.g., at the mold station 110 of FIG. 1). In the
example shown, components of two different sensor modules have been
molded onto the visible portion of the carrier body 300. Components
of a first sensor module 400 have been molded into the first gaps
317, 327 of the first and second sections 310, 320 and components
of a second sensor module 400' have been molded into the second
gaps 319, 329 of the first and second sections 310, 320.
[0063] The first sensor module 400 (FIG. 6) includes a first
housing portion 410 molded at the first gap 317 of the first
section 310 and a second housing portion 420 molded at the first
gap 327 of the second section 320. The first housing portion 410 is
formed to be generally complementary to the second housing portion
420. Each of the housing portions 410, 420 defines a depression
415, 425, respectively. When the housing portions 410, 420 are
assembled, the depressions 415, 425 align to form an analysis cell
within the sensor module 400. In a some embodiment, each depression
415, 425 is about 0.01 inches (0.25 millimeters) to about 0.05
inches (1.27 millimeters) across at a largest dimension and about
0.002 (0.05 millimeters) to about 0.005 inches (0.13 millimeters)
deep. In a preferred embodiment, each depression 415, 425 is about
0.03 inches (0.76 millimeters) across at the largest dimension and
about 0.003 (0.08 millimeters) deep.
[0064] At least one of the housing portions 410, 420 defines a
groove 407 to form a sample path between the analysis cell and the
exterior of the sensor module 400. In the example shown, the groove
407 is defined in the first housing portion 410. In another
embodiment, both housing portions 410, 420 can define channels that
align to form the groove 407. Channels configured to hold
continuous electrodes also are defined in at least one of the
housing portions 410, 420. In the example shown, electrode channels
412, 414 are defined in the first housing portion 410. In the
example shown, the electrode channels 412, 414 extend from one end
of the housing portion 410, through the anaysis cell, to an
opposite end of the housing portion 410. In one embodiment, the
electrode channels 412, 414 are V-shaped channels. In other
embodiments, however, the channels 412, 414 can have any suitable
shape (e.g., U-shaped, squared, etc.). In certain embodiments,
corresponding electrode channels can be defined in the second
housing portion 420.
[0065] In some embodiments, one or both housing portions 410, 420
also can include attachment members configured to secure the
housing portions 410, 420 together. For example, one of the housing
portions 410, 420 can include pegs or other protrusions configured
to mate with openings, depressions, or grooves defined in the other
of the housing portions 410, 420. In one embodiment, the first
housing portion 410 defines an extended protrusion 405 that is
configured to fit within a corresponding channel 426 defined in the
second housing portion 420 (e.g., see FIG. 8). In another
embodiment, the extended protrusion 405 provides an anchor which
can be embedded within a molded or welded section joining the two
housing portions 410, 420.
[0066] Support members also can be molded onto the carrier body 300
to couple the sensor module components to the carrier body 300
and/or to align the sensor module components on the carrier body
300. In FIG. 4, a first set of connecting support members 332
extend between the support members 312, 314 of the carrier body 300
and the first housing portion 410 to secure the first housing
portion 410 to the carrier body 300. A second set of connecting
support members 334 extend between the third support member 325 and
the second housing portion 420 410 to secure the second housing
portion 420 to the carrier body 300. In one embodiment, the
connecting support members 334 are integrally formed (see FIG. 6).
In other embodiments, the first housing portion 410 can be secured
to the third support member 315 of the first section and/or the
second housing portion 420 can be secured to support members
extending from the walls 321, 323 of the second section 320.
[0067] In the example shown, an alignment member 336 is arranged on
the third support member 315 of the first section 310. The
alignment member 336 defines grooves 325 configured to hold
continuous filaments that will form electrodes of the sensor
modules. The alignment member 336 has generally the same number of
grooves 325 as the first housing portion 410 has electrode channels
412, 414. In FIG. 4, the alignment member 336 defines two grooves
325. The grooves 325 of the alignment member 336 co-axially align
with the electrode channels 412, 414 of the first housing portion
410.
[0068] FIG. 5 shows the portion of the carrier 101 of FIG. 3 after
a first electrode 452 and a second electrode 454 have been routed
onto the molded sensor components (e.g., at the insertion station
130 of FIG. 1). In the example shown, the electrodes 452,454 are
routed on either side of the extended protrusion 405. The first
electrode 452 is routed into the first electrode channel 412 and
the second electrode 454 is routed into the second electrode
channel 414. Accordingly, the electrodes 452, 454 pass through the
depression 415 partially forming the analysis cell. Typically, the
first electrode 452 is a working electrode formed by coating sensor
chemistry onto an elongated member and the second electrode 454 is
a reference electrode formed from an uncoated elongated member.
[0069] In the example shown, the electrodes 452, 454 extend
longitudinally along the first section 310 of the carrier body 300
in continuous strands. Accordingly, the electrodes 452, 454 extend
from the first housing portion 410 of the first sensor module 400
to the first housing portion 410' of the second sensor module 400'.
The alignment member 336 aids in guiding the electrodes 452, 454
into position on the sensor modules 400, 400'. For example, each
electrode 452, 454 can be arranged within a groove 335 of the
alignment member 336.
[0070] In the example shown, the third support wall 315 of the
first section 310 has a depressed or "stepped out" portion to
accommodate the alignment member 336 and the electrodes 452, 454.
The depressed portion forms a channel 308 (FIG. 6) when the second
section 310 of the carrier body 300 is folded over the first
section 310. The electrodes 452, 454 are routed through the channel
308 when passing between components of the sensor modules 400,
400'.
[0071] FIG. 6 shows the portion of the carrier 101 of FIG. 3 after
the carrier 101 has been rolled or folded along the fold axis 304
(FIG. 3) to align the first and second sections 310, 320 of the
carrier body 300 (e.g., at fold station 140 of FIG. 1). In one
embodiment, the connecting members 307 extending between the first
and second sections 310, 320 of the carrier body 300 are broken at
their tapered centers 308 along the fold axis 304 as shown in FIG.
6. In other embodiments, however, the connecting members 307 bend
sufficiently to enable the first section 310 to align with the
second section 320.
[0072] The first housing portion 410 of the first sensor module 400
is aligned with the second housing portion 420 in FIG. 6. In one
embodiment, the protrusion 405 of the first housing portion 410
fits within the channel 426 of the second housing portion 426.
Further, the first housing portion 410' of the second sensor module
400' is similarly aligned with the second housing portion 420' of
the second sensor module 400'. In one embodiment, each sensor
module 400, 400' defines a gap 460, 460' at which electrodes (e.g.,
see reference nos. 572, 574 of FIG. 9) can be coupled to the
housing in contact with the electrodes.
[0073] FIG. 7 is an isometric view of the opposite side of the
portion of the carrier 101 shown in FIG. 6 after the opposing
components have been secured together (e.g., at joining station 150
of FIG. 1). The carrier body 300 has been broken in half at the
centers 308 of the connecting members 307. The index holes 302 of
the first and second sections 310, 320 of the carrier body 300
align. The first and second housing portions 410, 420 of the first
sensor module 400 also are visibly aligned with each other. When
the first housing portion 410 is aligned with the second housing
portion 420, the depressions 415, 425 defined in the housing
portions 410, 420 form an analysis cell through which the
electrodes 452, 454 pass. The groove 407 defined in the first
housing portion 410 forms a sample path extending from the analysis
cell to an exterior of the sensor module 400. Fluid can be provided
to the analysis cell, and hence the portion of the electrodes 452,
454 extending through the analysis cell, through capillary action
or wicking.
[0074] Furthermore, the first and second housing portions 410, 420
are joined together (e.g., via a weld, an overmold layer, or
another joining structure). In a preferred embodiment, the housing
portions 410, 420 are secured together using a selective laser
weld. For example, in one embodiment, the second housing portion
420, which does not contain active components, such as the
electrodes 452,454, is transparent to the laser while the first
housing portion 410, which contains the electrodes, is absorptive
to the laser energy, thereby establishing an interior plane for a
precise laser weld creating a hermetic seal for the analysis cell
and related component structures.
[0075] FIG. 8 is a partial, isometric view of the first sensor
module 400 after the sensor module 400 has been separated from the
carrier 101 (e.g., at the separation station 160 of FIG. 1). The
first housing portion 410 is shown as transparent in FIG. 1 so that
the interior configuration of the sensor module 400 is visible. The
electrodes 452, 454 extend through the channels 412, 414 defined in
the first housing and through the analysis cell formed by the
depressions 415, 425. In FIG. 8, the electrodes 452,454 terminate
at the periphery of the housing.
[0076] FIGS. 9-15 walk through another application in which another
example sensor module 500 (see FIGS. 9 and 10) is manufactured in
accordance with the principles of the present disclosure. For
example, the sensor module 500 can be fabricated using the
manufacturing system 100 of FIG. 1 and/or the manufacturing process
200 of FIG. 2. The sensor module 500 includes a module body 501
having a distal end 502 positioned opposite from a proximal end
503. The module body 501 includes a first housing portion 504
secured to a second housing portion 506 at a part line 506.
[0077] The module body 501 includes an analysis cell housing 507
positioned adjacent the distal end 502 and a skin piercing member
anchor 508 positioned adjacent the proximal end 503. A flexible
linkage 509 mechanically connects the analysis cell housing 507 to
the skin piercing member anchor 508. The flexible linkage 509 is
configured to allow the analysis cell housing 507 and the skin
piercing member anchor 508 to move relative to one another along an
axis A that extends through the module body 501 from the proximal
end 503 to the distal end 502 (see FIG. 10).
[0078] The skin piercing member anchor 508 is configured to
slideably secure a skin piercing member (e.g., a cannula, a needle,
a lancet, or other structure) 518 within an axially extending
passage 514 defined in the analysis cell housing 507. The flexible
linkage 509 of the module body 501 preferably has a compressible
configuration that enables the flexible linkage 509 to compress
axially along the axis A as the skin piercing member anchor 508
moves the skin piercing member 518 from a retracted position to an
extended position to pierce the skin of the patient and obtain a
fluid sample (e.g., a blood sample).
[0079] The analysis cell housing 507 defines an analysis cell 512
(FIG. 10) at which the fluid sample can be analyzed using a sensor
structure, such as a wired enzyme sensor arrangement, in fluid
communication with the analysis cell 512. The analysis cell 512 has
a first end in fluid communication with a capillary slot 513
leading to the passage 514 and an opposite, second end at which a
vent 511 is defined. The passage 514 includes a distal end 515
positioned opposite from a proximal end 516 and is configured to
transport a fluid sample from a distal end 502 of the module body
501 to the analysis cell 512.
[0080] The analysis cell housing 507 also defines first and second
electrode mounting structures (e.g., V-grooves) 517, 519 extending
from a proximal end of the analysis cell housing to a distal end.
First and second electrodes (not shown) extend within the mounting
structures 517, 519 across the analysis cell 512 to contact
receivers (e.g., receptacles, pads, slots, or other structures)
534, 536 for receiving and retaining electrode contacts 530, 532
(see FIG. 10). The contacts 530, 532 include exposed tips
protruding outwardly from the analysis cell housing 507 to enable
transmission of signals generated by the electrodes to metering
electronics.
[0081] Additional details on the sensor module 500, monitoring and
delivery systems utilizing the sensor module 500, and monitoring
and delivery processes that can be implemented using the sensor
module 500 can be found in copending application no. 61/114,844,
filed Nov. 14, 2008, and having attorney docket no. 11554.13USP1,
the disclosure of which is hereby incorporated by reference
herein.
[0082] Referring to FIGS. 11-15, the first and second housing
portions 504, 506 of the sensor module 500 can be molded on
opposite sides of a carrier, such as the carrier 600 of FIG. 11.
FIG. 11 shows a portion of one example carrier 600 that can be
indexed through the different processing stations 110, 120, 130,
140, 150, 160 of the manufacturing system 100 of FIG. 1. The
carrier 600 includes a generally flat carrier body 601 defining a
profile that is configured to support the components of the sensor
module to be manufactured. One or more components can be molded to
the carrier body 601 as the carrier 600 is indexed. In certain
embodiments, multiple components of one sensor module can be molded
across the carrier body 601.
[0083] The carrier body 601 also defines at least one series of
index holes 602 configured to receive index pins to advance the
carrier through a manufacturing system. In the example shown, the
carrier body 601 defines two series of index holes 602. In other
embodiments, however, the carrier body 601 can define greater or
fewer series of index holes 602. In a preferred embodiment, the
carrier body 601 is produced by roll stamping a high-precision
profile on a stainless steel or suitable polymer tape and storing
the prepared tape on a collector reel, such as the first carrier
reel 102 of FIG. 1.
[0084] The carrier body 601 includes a fold feature 605 that splits
the carrier body 601 into a first section 610 and a second section
620 along a fold axis 604. Folding the carrier body 601 along the
fold axis 604 aligns the first section 610 with the second section
620. Accordingly, the fold feature 605 of the carrier body 601
enables opposing portions of sensor components to be molded onto
the first and second sections 610, 620 of the carrier body 601 and
subsequently assembled together by folding the carrier body 601
along the fold axis 604.
[0085] In general, the fold feature 605 is a weakened or reduced
portion of the carrier body 601 at which the carrier body 601 is
configured to bend and/or break. In the example shown, the fold
feature 605 includes multiple connecting members 607 extending
between the first and second sections 610, 620. The connecting
members 607 have a tapered center 608 that is configured to bend to
enable the carrier body 601 to be folded at the fold feature 605.
In a preferred embodiment, the fold feature 605 of the carrier body
601 is a midline fold feature that splits the carrier body 601
along a central axis into two halves. In other embodiments,
however, the fold feature 605 can split the carrier body 601 into
sections 610, 620 of different sizes.
[0086] The carrier body 601 shown in FIG. 11 has a profile
configured to support at least two molded components of a sensor
module. Each section 610, 620 includes a first support wall 611,
621 and a second support wall 613, 623. One or more support members
extend inwardly from the support walls 611, 613, 621, 623 of the
each section 610, 620, respectively. The support members are
configured to provide support for molded components of the sensor
module. The sensor components are molded onto the support members
between the support walls 611, 613, 621, 623.
[0087] For example, in FIG. 11, the first section 610 includes a
first support member 612 extending between the support walls 611,
613 at a first end of the carrier profile. The first section 610
also includes second and third support members 614, 616 extending
between the support walls 611, 613 at a position spaced from the
first support member 612. A fourth support member 618 also extends
inwardly from the second support wall 613. The second section 620
includes a first support member 622 extending between the support
walls 621, 623 at the first end of the carrier profile and a second
support member 624 extending between the support walls 621, 623 at
a position spaced from the first support member 622.
[0088] FIG. 12 shows the portion of carrier 600 of FIG. 11 after
sensor module components have been molded onto the body 601 of the
carrier 600 (e.g., at the mold station 110 of FIG. 1). In the
example shown, components of a single sensor module 500 have been
molded onto the visible portion of the carrier body 601. A first
housing portion 504 has been molded onto the support members 612,
614, 616, 618 of the first section 610 of the carrier 600. A second
housing portion 506 has been molded onto the support members 622,
624 of the second section 620 of the carrier 600. The first housing
portion 504 is formed to be generally complementary to the second
housing portion 506.
[0089] Each housing portion 504, 506 includes an analysis cell
housing section 707, 807, a flexible linkage section 709, 809, and
an anchor section 708, 808, respectively. In one embodiment, the
analysis cell housing section 707 of the first housing portion 504
defines a depression 712 that at least partially forms the analysis
cell 512 when the housing portions 504, 506 are subsequently joined
together. In one embodiment, the analysis cell 512 is fully defined
by the depression 712 in the analysis cell housing section 707. In
another embodiment, a corresponding depression (not shown) is
formed in the analysis cell housing section 807 of the second
housing portion 506. In a some embodiment, the depression 712 is
about 0.01 inches (0.25 millimeters) to about 0.05 inches (1.27
millimeters) across at a largest dimension and about 0.002 (0.05
millimeters) to about 0.005 inches (0.13 millimeters) deep. In a
preferred embodiment, the depression 712 is about 0.03 inches (0.76
millimeters) across at the largest dimension and about 0.003 (0.08
millimeters) deep.
[0090] The first and second housing portions 504, 506 each define a
channel 716, 816 that extends between proximal and distal ends 702,
703, 802, 803 of the housing portion 504, 506, respectively. When
the housing portions 504, 506 are subsequently joined together, the
channels 716 and 816 form the passageway 514 through which a fluid
sample can be transported to the analysis cell 512. In other
embodiments, the passageway 514 can be formed entirely by the
channel 716 within the first housing portion 504 or the channel 816
within the second housing portion 506.
[0091] Each channel 716, 816 includes a first section 713, 813, a
second section 714, 814, and a third section 715, 815,
respectively. The first sections 713, 813 of the channels 716, 816
have a frustro-conical shape configured to allow blood or other
fluid to enter the passageway 514 formed by the channels 716, 816.
The second section 714, 814 of the channels 716, 816 extend between
the first sections 713, 813 and the depression 712. The third
sections 715, 815 of the channels 716, 816 extend from the
depression 712 to the opposite end of the analysis cell housing
section 707, 807.
[0092] The second sections 714, 814 have diameters generally
sufficient to enable sliding movement of a piercing member, such as
piercing member 518 of FIG. 10, and to enable passage of a sample
fluid alongside the piercing member 518. The third sections 715,
815 have diameters that are less than the diameters of the second
sections 714, 814. In one embodiment, the diameters of the third
sections 715, 815 are sized to enable sliding movement of the
piercing member 518, but to inhibit passage of a sample fluid
alongside the piercing member 518.
[0093] The analysis cell housing section 707 of the first housing
portion 504 also can define electrode channels 717, 719 in which
first and second continuous electrodes (not shown) can be routed
through the analysis cell housing section 807. In one embodiment,
the electrode channels 717, 719 are V-shaped channels. In other
embodiments, however, the channels 717, 719 can have any suitable
shape (e.g., U-shaped, squared, etc.). In certain embodiments,
corresponding electrode channels 717, 719 can be defined in the
second housing portion 506.
[0094] In one embodiment, the analysis cell housing section 707 of
the first housing portion 504 defines cavities or slots 734, 736 at
which the electrodes are exposed to contact 530, 532 extending
through the analysis cell housing section 707. These contacts 530,
532 include exposed tips that extend outwardly from the first
housing portion 504 to enable electrical coupling to processing
and/or metering electronics. Accordingly, signals generated at the
electrodes can be forwarded to such electronics via the contacts
530, 532.
[0095] In some embodiments, these contacts 530, 532 can be coupled
to the carrier 600 on which the housing portions 504, 506 are
molded prior to the manufacturing process. For example, in FIG. 11,
the contacts 530, 532 are coupled to support members 614, 616 of
the first section 610 of the carrier 600. Accordingly, the first
housing portion 504 can be overmolded around the contacts 530, 532
to embed the contacts 530, 532 in the first housing portion 504. In
other embodiments, however, these contacts 530, 532 are inserted
into the slots 734, 736 at the completion of the manufacturing
process.
[0096] In some embodiments, one or both housing portions 504, 506
also can include attachment members configured to secure the
housing portions 504, 506 together. For example, one of the housing
portions 504, 506 can include a peg or other protrusion configured
to mate with an opening, depression, or groove, or slot defined in
the other of the housing portions 504, 506. In one embodiment, the
first housing portion 504 defines an extended protrusion 725 that
is configured to fit within a corresponding slot 825 defined in the
second housing portion 506 (e.g., see FIG. 13).
[0097] FIG. 13 shows the portion of the carrier 600 of FIG. 12
after a first electrode 552 and a second electrode 554 have been
routed onto the molded sensor components (e.g., at the insertion
station 130 of FIG. 1). In the example shown, the electrodes
552,554 are routed through channels 717, 719 of the first housing
portion 504. Accordingly, the electrodes 552, 554 pass through the
depression 712 partially forming the analysis cell 512. Typically,
the first electrode 552 is a working electrode formed by coating
sensor chemistry onto an elongated member and the second electrode
554 is a reference electrode formed from an uncoated elongated
member.
[0098] FIG. 14 is an isometric view of the portion of the carrier
600 after the carrier 600 has been rolled or folded along the fold
axis 605 (FIG. 11) to align the first and second sections 610, 620
of the carrier body 600 (e.g., at fold station 140 of FIG. 1). In
one embodiment, the connecting members 607 extending between the
first and second sections 610, 620 of the carrier body 600 are
broken at their tapered centers 608 along the fold axis 604 as
shown in FIG. 14. In other embodiments, however, the connecting
members 607 bend sufficiently to enable the first section 610 to
align with the second section 620 without breaking the carrier 600
into two sections.
[0099] The first housing portion 504 of the sensor module 500 is
aligned with the second housing portion 506 in FIG. 14. In one
embodiment, the protrusion 725 of the first housing portion 504
fits within the slot 825 of the second housing portion 506. When
the first housing portion 504 is aligned with the second housing
portion 506, at least the depressions 712 defined in the first
housing portion 504 forms an analysis cell 512 through which the
electrodes 552, 554 pass. The channels 716, 816 defined in the
first and second housing portions 504, 506 form the sample path 514
extending through the analysis cell 512. Fluid can be provided to
the analysis cell 512, and hence the portion of the electrodes 552,
554 extending through the analysis cell, through capillary action
or wicking.
[0100] The first and second housing portions 504, 506 are joined
together (e.g., via a weld, an overmold layer, or another joining
structure). In a preferred embodiment, the housing portions 504,
506 are secured together using a selective laser weld. For example,
in one embodiment, the second housing portion 506, which does not
contain active components, such as the electrodes 552,554, is
transparent to the laser while the first housing portion 504, which
contains the electrodes 552, 554, is absorptive to the laser
energy, thereby establishing an interior plane for a precise laser
weld creating a hermetic seal for the analysis cell and related
component structures.
[0101] FIG. 15 is an isometric view of the portion of the carrier
600 shown in FIG. 14 after the opposing components have been
secured together (e.g., at joining station 150 of FIG. 1). The
carrier body 600 has been broken in half at the centers 608 of the
connecting members 607. The index holes 602 of the first and second
sections 610, 620 of the carrier body 600 align. The first and
second housing portions 504, 506 of the sensor module 500 also are
visibly aligned with each other.
[0102] Additional features can be added to the interior of the
sensor modules 400, 500 after the support components are molded on
the carrier body 300, 600 and prior to folding the carrier body
300, 600. For example, in certain embodiments, a piercing member
(e.g., needle cannula 518 of FIG. 10) can be added to the sensor
module (e.g., sensor module 500 of FIGS. 9 and 10) to aid in
obtaining a fluid sample. In other embodiments, additional features
can be added to the sensor module after completion of the
manufacturing process (e.g., manufacturing process 200 of FIG. 2).
For example, in certain embodiments, an reservoir containing
insulin or another drug can be added to the sensor module after the
sensor module has been separated from the carrier. Of course, the
piercing member also can be added to the sensor module after
separation from the carrier.
[0103] Additional details regarding example sensor modules that can
be manufactured using the systems and processes disclosed herein
can be found in copending application Ser. Nos. 61/114,829 and
61/114,844 (having attorney docket nos. 11554.11USP1 and
11554.13USP1), filed Nov. 14, 2008, the disclosures of which are
hereby incorporated herein by reference.
[0104] FIG. 16 illustrates another manufacturing system 900 by
which sensor modules may be assembled. In some implementations, all
of the components of the sensor 908 are assembled to form a first
housing portion 902 and a second housing portion 904. In some
implementations, the first and second housing portions 902, 904
form first and second halves of the sensor module 908. In other
implementations, the first housing portion 902 forms more or less
than half of the sensor module body. At least one of the housing
portions 902, 904 defines an inlet, a test chamber, and passages
therebetween. A skin-piercing member is positioned on one of the
housing portions 902, 904.
[0105] In some implementations, the manufacturing system 900
includes a first station 901 for depositing electrodes (e.g.,
composite sensor fibers) onto the first housing portions 902, a
second station 903 for joining the housing portions 902, 904, and a
third station 905 for separating the joined housings from each
other to form the sensor modules 908. Of course, in other
implementations, the same station may perform some or all of these
processes. In some implementations, the sensor components may be
positioned on one or more conveyor belts 912, fluid streams,
pallets or other transportation structures to convey the components
through the manufacturing system.
[0106] FIG. 17 illustrates one example implementation of a first
station 901 of the manufacturing system 900. The first station 901
is configured to deposit one or more sensor fibers 906 onto the
first housing portion 902 of one or more sensor modules 908. In one
example implementation, the sensor fiber includes a composite
sensor fiber having a dielectric core, a conductive layer, and a
sensing layer. In some implementations, the first station 901
deposits a single sensor fiber 906 onto each first housing portion
902. In other implementations, the first station 901 deposits
multiple sensor fibers 906 onto each first housing portion 902. For
example, the first station 901 may deposit a working electrode and
a counter electrode onto each first housing portion 902.
[0107] In some implementations, the first station 901 dispenses the
composite sensor fibers 906 onto a single first housing portion 902
on each duty cycle. In other implementations, the first station 901
dispenses the composite sensor fibers 906 onto multiple first
housing portions 902 on each duty cycle. In the example shown, the
first station 901 dispenses the composite sensor fibers 906 onto
five first housing portions 902 on each duty cycle. In other
implementations, the first station 901 may dispense the composite
sensor fibers 906 onto greater or fewer housing portion 902 on each
duty cycle.
[0108] In some implementations, the composite sensor fibers 906 are
dispensed from one or more reels 910 into channels defined in the
first housing portions 902. In certain implementations, the first
station 901 includes a first set of reels 910 that dispense the
composite sensor fibers 906 onto a first row of first housing
portions 902. In other implementations, the first station 901
includes multiple sets of reels 910, each set dispensing sensor
fibers 906 onto a row of first housing portions 902.
[0109] In certain implementations, the first station 901 also
includes one or more cutting structures 914 that disconnect the
dispensed sensor fibers 906 from the reels 910. In some
implementations, the cutting structures 914 cut the sensor fibers
906 at extreme ends of the set of first housings 902. In such
implementations, a continuous length of each sensor fiber 906
extends through all of the first housing portions 902 at the first
station 901. In other implementations, the cutting structures 914
cut the sensor fibers 906 to separate the sensor fibers 906 of each
first housing portion 902.
[0110] FIGS. 18 and 19 are top plan views of example
implementations of the first station 901 of FIG. 17. The first
station 901 includes a conveyer 912 on which multiple first housing
portions 902 are positioned. In certain implementations, each first
housing portion 902 includes a skin-piercing member (e.g., a
lancet, a needle, etc.) 915. In other implementations, the
skin-piercing member 915 is positioned in a second housing portion
904. In the example station 901 shown in FIG. 18, the first housing
portions 902 are oriented so that the sensor fibers 906 are
dispensed generally parallel to a longitudinal axis of the
skin-piercing members 915. In the example station 901 shown in FIG.
19, the first housing portions 902 are oriented so that the sensor
fibers 906 are dispensed generally perpendicular to a longitudinal
axis of the skin-piercing members 915.
[0111] FIG. 20 illustrates one example implementation of a second
station 903 of the manufacturing system 900. The second station 903
is configured to join together a second housing portion 904 to a
first housing portion 902 to enclose a skin-piercing member 915 and
one or more composite sensor fibers 906 to form a sensor module
908. In some implementations, the second station 903 couples
together the first and second housing portions 902, 904 of multiple
sensor modules 908 per cycle. In other implementations, the second
station 903 forms one sensor module 908 at a time.
[0112] In some implementations, the second station 903 may clamp
the first and second housing portions 904 together. In other
implementations, the second station 903 may weld together (e.g.,
sonic-weld or laser-weld) the first and second housing portions
904. In still other implementations, the second station 903 may
press-fit or snap-fit the first and second housing portions 904
together. In still other implementations, the second station 903
may affix the first and second housing portions 904 together using
adhesive.
[0113] In certain implementations, the continuous length of each
sensor fiber 906 still extends through all of the housing portions
902, 904 at the second station 903 while the housing portions 902,
904 are coupled together. For example, the second station 903 may
install a plurality of second housing portions 904 on a plurality
of first housing portions joined along a continuous length of one
or more composite sensor fibers 906. In the example shown in FIG.
20, the second station 903 is pressing five second housing portions
904 onto five first housing portions 902 that are connected by a
continuous length of at least one electrode 906.
[0114] FIG. 21 illustrates one example implementation of a third
station 905 of the manufacturing system 900. The third station 905
is configured to separate the sensor modules 908 from each other by
cutting the continuous length of the one or more composite sensor
fibers 906 extending therebetween. In some implementations, the
sensor fibers 906 are cut with a laser. In other implementations,
the sensor fibers 906 are cut with a knife. In other
implementations, the sensor fibers 906 are cut with a nipper. In
other implementations, the sensor fibers 906 are cut with pneumatic
shears.
[0115] The third station 905 includes at least one cutting device
914. In some implementations, the third station 905 includes a
single cutting device 914. For example, the third station 905 may
be configured to cut the composite sensor fibers 906 at only one
side of the module 908. In other implementations, the third station
905 includes multiple cutting devices 914. For example, the third
station 905 may be configured to cut the composite sensor fibers
906 on both sides of the sensor module housing.
[0116] In accordance with some aspects, the sensor module 500 of
FIGS. 9-15 may be manufactured using the manufacturing system 900.
For example, FIG. 22 shows the sensor module 500 with a first
composite sensor fiber 906a and a second composite sensor fiber
906b positioned between the first and second housing portions 504,
506. The longitudinal axis L of each composite sensor fiber 906a,
906b extends generally parallel to the movement axis A of the
skin-piercing member 518.
[0117] In accordance with certain aspects, the cut ends of the
sensor fibers 906a, 906b are positioned at opposite surfaces 540,
542 of the housing 501. In some implementations, the opposite
surfaces 540, 542 are located at extreme ends of the housing 501
(e.g., at opposite sides along the length of the housing 501 or at
opposite sides along the width of the housing 501). In other
implementations, the opposite surfaces 540, 542 are located on
opposite sides of a portion of the housing 501. In the example
shown in FIG. 22, the sensor fibers 906a, 906b have first cut ends
at one side 540 of the analysis cell housing 507 and second cut
ends at an opposite side 542 of the analysis cell housing 507.
[0118] As noted above, the sensor fiber contacts 530, 532 include
exposed pads protruding outwardly from the analysis cell housing
507 to enable transmission of signals generated by the sensor
fibers 906a, 906b to metering electronics. In some implementations,
the exposed pads 530, 532 are located at the cut ends of the sensor
fibers 906a, 906b. In other implementations, the exposed pads 530,
532 are located offset a distance from the cut ends of the sensor
fibers 906a, 906b. In the example shown in FIG. 18, the contact
pads 530, 532 extend from a surface transverse to the opposite
surfaces 540, 542 at which the cut fiber ends terminate.
[0119] In accordance with other aspects, another example sensor
module 920 may be manufactured using the manufacturing system 900.
For example, FIG. 23 shows the example sensor module 900 with a
first composite sensor fiber 906a and a second composite sensor
fiber 906b positioned between first and second housing portions
922, 924. The longitudinal axis L of each composite sensor fiber
906a, 906b extends generally perpendicular to a movement axis A2 of
the skin-piercing member 928.
[0120] In accordance with certain aspects, the sensor fibers 906a,
906b extend from a first location at one surface 940 of the sensor
920 to a second location at an opposite surface 942 of the sensor
920. In some implementations, the opposite surfaces 940, 942 are
located at extreme ends of the sensor module 920. In other
implementations, the opposite surfaces 940, 942 are located on
opposite sides of a portion of the sensor 920. In the example shown
in FIG. 23, the sensor fibers 906a, 906b extend across a width of
the sensor module 920 to opposite side surfaces 940, 942 at a front
of the sensor module 920.
[0121] The sensor module 920 includes electrode contacts 930, 932
that connect to the composite sensor fibers 906a, 906b. In some
implementations, the sensor fiber contacts 930, 932 include exposed
pads 934, 936, respectively, protruding outwardly from the housing
of the sensor module 920 to enable transmission of signals
generated by the sensor fibers 906a, 906b to metering electronics.
In some implementations, the exposed pads 934, 936 are located at
the cut ends of the sensor fibers 906a, 906b. In other
implementations, however, the exposed pads 934, 936 are offset from
the cut ends of the sensor fibers 906a, 906b. In the example shown
in FIG. 23, the contact pads 934, 936 are offset rearwardly along
the opposite surfaces 940, 942 from the cut ends of the sensor
fibers 906a, 906b.
[0122] Additional details regarding the sensor module 920 can be
found in U.S. Provisional Application No. 61/430,384, filed Jan. 6,
2011, and titled "Sensor Module with Enhanced Capillary Flow," the
disclosure of which is hereby incorporated herein by reference.
Additional details regarding example sensor fibers suitable for use
in sensor modules manufactured as described above can be found in
U.S. Pat. Nos. 5,264,105; 5,356,786; 5,262,035; and 5,320,725, the
disclosures of which are incorporated by reference herein. Further
examples of sensor fibers are described in U.S. application Ser.
Nos. 13/129,325, filed May 13, 2011, and titled "Electrochemical
Sensor Module," the disclosure of which is incorporated by
reference herein. Other examples of sensor fibers are described in
PCT Publication Nos. WO 2009/032760 and WO 2009/051901, the
disclosures of which are incorporated by reference herein.
[0123] The above specification provides examples of how certain
aspects may be put into practice. It will be appreciated that the
aspects can be practiced in other ways than those specifically
shown and described herein without departing from the spirit and
scope of the present disclosure.
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